1. Field of the Invention
The present invention relates to a sterile, disposable padding device that can be positioned on the edge of an X-ray plate in a mammography system. More particularly, the present invention relates to a padding device that reduces the discomfort experienced by a patient as the patient's body is pressed against the hard edges of an X-ray plate during a mammographic examination.
2. Prior Art Statement
A mammographic examination, commonly called a mammography, is when X-ray images are obtained of a patient's breast tissues and the surrounding muscles. By viewing X-ray images obtained during a mammography, abnormalities such as malignancies and cysts can be detected long before they can be detected in a conventional tactile examination. Consequently, mammographies have become an essential tool in providing early detection of breast cancer and other diseases that effect the tissues of the breast. Early detection in breast cancer and like ailments is essential in effectively treating and curing the disease. As such, the development of mammography systems in medicine and the increasing number of patients who receive regular mammographic examinations has resulted in the early detections of many cases of breast cancer and has greatly increased the cure rate for treating breast cancer.
Mammography has become such an important part of the early detection of diseases of the breast, that many doctors now recommend that women over the age of forty receive annual mammographies as part of their routine medical care. By receiving annual examinations, it is probable that if a woman does ever develop breast cancer or another disease of the breast, then the annual mammography will detect that disease at an early stage where the likelihood of successfully treating the disease is at its highest. A mammography is not an overly time consuming or expensive medical procedure, yet every year many women do not submit themselves to a mammographic examination. As a result, many cases of breast cancer and other diseases of the breast are going undetected. The longer the disease goes without detection, the less likely it is that the disease can be successfully treated. Consequently, by not having annual mammographies, many women are jeopardizing their health.
One of the primary reasons women choose not to receive a mammography is that the mammography causes a great deal of physical discomfort. In a mammography, X-ray images are taken of a patient's breast from different perspectives. In order to include as much breast tissue in each X-ray image, the patient is required to lean into the X-ray plate as the X-ray images are taken. As will be later explained, it is the force of the X-ray plate against various parts of the patient's body that causes a large part of the discomfort experienced.
Referring to FIG. 1, there is shown a conventional mammography system 10 such as is currently commercially manufactured by General Electric and sold under the model name SENOGRAPHE 6OOT SENIX H.F.. The mammography system 10 includes an X-ray source 12, an X-ray plate 14 and a compression plate 16 positioned between the X-ray plate 14 and X-ray source 12. As will be later explained, the compression plate 16 is movable between the X-ray source 12 and the X-ray plate 14 and is used to compress breast tissue against the X-ray plate 14 before the X-ray images are taken. The X-ray plate 14 has a top surface 18 on which a patient's breast tissue will eventually rest. An X-ray film cartridge 20 slides into an opening below the top surface 18. X-ray radiation emanates from the X-ray source 12, passes through the compression plate 16, the patient's breast tissue and the top surface 18 of the X-ray plate 14 to create the desired X-ray images on the X-ray film cartridge 20.
As a patient's breast tissue is placed on the X-ray plate 16, the patient's body contacts the face surface 22 of the X-ray plate 14. The face surface 22 is rigid, having top edge 24 that joins the face surface 22 to the top surface 18, and two corner edges 26, 27 that join the face surface 22 to the two side surfaces 28, 29 of the X-ray plate 14. Different parts of a patient's body contact the face surface 22, its top edge 24 and its two corner edges 26, 27 during the mammographic examination. As the sharp rigid shape of the top edge 24 and the corner edges 26, 27 press against the patient's body, great discomfort is caused to the patient. Additionally, as a patient's skin contacts the face surface 22 of the X-ray plate 14, the X-ray plate 14 cannot be kept sterile unless it is cleaned and disinfected after each use. Furthermore, the X-ray plate 14 is often cold, causing discomfort to the patient upon contact with the patient's body.
During a mammographic examination, X-ray images are obtained for a patient's breast tissue from a plurality of perspectives. Referring to FIG. 2, there is shown a patient 30 undergoing a mammography on the previously described mammography system 10 so as to obtain a cranicaudal projection of the patient's breast 31. To obtain a cranicaudal projection, the patient 30 must lean her body against the face surface 22 of the X-ray plate 14 so that her breast 31 extends as far as possible across the top surface 18 of the X-ray plate 14. The compression plate 16 then is used to compress the breast 31 against the compression plate 16 so as to flatten the breast 31. When positioned for a craniocaudal projection, the patient's ribs are pressed hard against the face surface 22 of the X-ray plate 14. Furthermore, one of the corner edges 26 of the X-ray plate 14 is pressed against the patient's sternum and the sharp top edge 24 of the X-ray plate 14 is pressed hard against the underside of the patient's breast 31. The contact of the X-ray plate 14 against the patient 30 at these positions causes great discomfort to the patient 30.
In FIG. 3, the patient 30 is shown positioned with the mammography system 10 so as to obtain a mediolateral oblique view of the patient's breast 31. In this orientation, one edge corner 27 of the X-ray plate 14 is placed under the patient's arm 33 where it is pressed into the patient's axilla and causes great discomfort. The opposite edge corner 26 of the X-ray plate is pressed against the patient's rib cage. Furthermore, the sharp top edge 24 of the X-ray plate 14 is pressed against the underside of the breast 31. The position of the X-ray plate 14 during the mediolateral oblique view is again extremely uncomfortable to the patient 30.
In FIG. 4, the patient 30 is shown positioned with the mammography system 10 so as to obtain a lateromedial projection of the patient's breast 31. In this orientation the X-ray plate 14 passes down the center of the patient's torso, wherein one corner edge 26 of the X-ray plate 14 presses against the neck of the patient, while the opposite end corner 27 presses against the patient's stomach. The top edge 24 of the X-ray plate 14 is pressed across the sternum, and depending upon the size of the patient 30, may cross the throat of the patient. The position of the X-ray plate 14 during lateromedial projection is again extremely uncomfortable to the patient 30.
It will be understood that in the practice of mammographic examinations, there are many different projected orientations that may be taken of a patient's breast. In each of these projected orientations, however, the patient is required to lean against the face surface of the X-ray plate. Consequently, the patient experiences discomfort as the hard edges and corners of the X-ray plate press into the patient's body. In view of the discomfort caused by mammography systems, there exists a need for a disposable padding device that can be placed over the edges of the X-ray plate before a patient is required to lean against the X-ray plate. As such, the hard corners and edges of the X-ray plate can be cushioned while providing a disposable sanitary surface.
The prior art is replete with devices that are used to cushion the edges of objects, however these devices cannot be applied to mammography systems without adversely effecting the operation of the mammography system. For example, in U.S. Pat. No. 4,710,992 to Falwell et al, a padding device is disclosed for use in padding the hard edges of a bed rail. The Falwell device uses metal spring clips to form a friction fit during installation. The spring clips are radiopaque, as such the Falwell device cannot be used on a mammography system because the spring clips would obstruct the X-ray beam used to create the X-ray images being collected.
In U.S. Pat. No. 4,703,531 to Bissett, a padding device is disclosed that is designed to cover a support beam for a bed. The padding device is typical of many prior art padding devices in that no importance is placed on the radiopaqueness of the design. The Bissett device utilizes thick padding, wooden blocks, metal clamps and metal staples in its construction. As a result, the Bissett device cannot be used to pad an X-ray plate because the Bissett device would block the impinging X-ray beam and cause useless X-ray images.
Another problem with many conventional prior art padding devices is that they are expensive to manufacture and difficult to install, therefore making such prior art padding devices impractical for use on a mammography system. For example, in U.S. Pat. No. 4,117,782 to Cahill, entitled GUARD FOR PREVENTING HUMAN INJURIES ON IMPACT WITH FURNISHINGS, a padding guard is described that is tied around the edges of a piece of furniture with a length of flexible strapping. In such an arrangement, the time and labor required in attaching and removing the padding from the edge of an object would preclude its use as an effective one-time-use, sterile and disposable device.
It is therefore an objective of the present invention to provide a padding device that can be attached to the hard edges of an X-ray plate in a mammography system, wherein the present invention padding device is sterile, disposable, easy to install and remove, inexpensive to manufacture and does not adversely effect the X-ray images being created during the mammography.